|Policy & Guidance|
|Compliance & Oversight|
|Research Involving Human Subjects|
|Office of Laboratory Animal Welfare (OLAW)|
|Animals in Research|
|Peer Review Policies & Practices|
|Intellectual Property Policy|
|Acknowledging NIH Funding|
|Invention Reporting (iEdison)|
|NIH Public Access|
What NIH Grantees Need to Know About FDAAA
This Web site provides information to help NIH applicants and grantees (recipients of extramural grants, including cooperative agreements) to understand their roles and responsibilities in relation to the Food and Drug Administration Amendments Act (FDAAA) of 2007.
The information on this site may not apply to NIH contracts or NIH intramural research.
FDAAA for NIH Grantees: The Basics
Proposed Policies and Rules:
NIH Implementation of FDAAA
Further Resources for NIH Grantees
For Additional InformationAdditional questions about compliance with the NIH implementation of FDAAA may be directed to the NIH Office of Extramural Research at OEPmailbox@mail.nih.gov.